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The Safety and Effectiveness of Thermosensitive Endoscopic Ultrasound Couplant: A Multicenter Clinical Randomized Controlled Study

The Safety and Effectiveness of Thermosensitive Endoscopic Ultrasound Couplant: A Multicenter Clinical Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087556
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal lesions

Interventions

Thermosensitive couplant group:The thermosensitive couplant is delivered to the lesion site using the endoscopic forceps channel. Then insert in the mini ultrasound probe to observe and collect EUS im
Normal saline group:Normal saline is used as an ultrasonic medium using conventional methods to observe and collect EUS images of the lesion site.

Sponsors

Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years, gender is not limited; 2. Esophageal protruding lesion necessitating EUS probe examination; 3. Willing to actively participate and adhere to the experimental protocol, accept regular follow-up examinations as planned, and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with severe heart disease (NYHA classification = class ?), lung disease or a pacemaker implant, who cannot tolerate upper gastrointestinal endoscopy; 2. Those with coagulation disorders (prothrombin time = 18 s), those with hemorrhagic diseases, and those taking oral anticoagulants; 3. Patients with corrosive esophagitis; 4. Those who cannot tolerate painless endoscopic ultrasound; 5. Those with acute severe throat diseases, unable to insert an endoscope; 6. Women who are pregnant or lactating during screening; 7. Those who have participated in other clinical trials within three months before the trial. 8. Other situations deemed unsuitable for selection by the researchers.

Design outcomes

Primary

MeasureTime frame
Endoscopic ultrasound image quality;Routine blood analysis;Inflammatory factors;Liver function;Kidney function;Electrolyte;Blood fat;Urine routine test;Stool routine test;Adverse events during endoscopic ultrasound;

Secondary

MeasureTime frame
Thermosensitive couplant/saline dosage;Time consuming of endoscopic ultrasound;Adverse events after endoscopic ultrasound;

Countries

China

Contacts

Public ContactShiming Yang

Second Affiliated Hospital of Army Medical University

13228686589@163.com+86 132 2868 6589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026